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GOOD MANUFACTURING PRACTICE GUIDELINE FOR …

Ethiopian Food, Medicine & Healthcare Administration & Control Authority (EFMHACA). GOOD MANUFACTURING PRACTICE GUIDELINE . FOR PHARMACEUTICAL PRODUCTS. MAIN PRINCIPLES. First Edition, 2014. Addis Ababa, Ethiopia Table of Contents ACKNOWLEDGMENTS .. viii DEFINITIONS .. 2. CHAPTER ONE-QUALITY 11. Principle .. 11. Quality Assurance .. 11. Good MANUFACTURING PRACTICE for 12. Quality Control .. 12. Product Quality Review .. 13. Quality Risk Management .. 14. CHAPTER TWO- SANITATION AND HYGIENE .. 15. Principle .. 15. General .. 15. CHAPTER THREE-PREMISES .. 16. Principle .. 16. Premises .. 16. General Requirement .. 16. Production Area .. 16. Storage Area .. 17. Quality Control Area .. 18. Ancillary Area .. 18. Principle .. 19. General Requirement.

The guideline describes a comprehensive quality system model, which, if implemented, will allow manufacturers to support and sustain robust, modern quality …

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